Receives CE Mark for Covid-19 testing
ABERCYNON, Wales, Aug. 9, 2022 /PRNewswire/ -- Imspex Diagnostics Ltd today announced that it has received CE mark for its BreathSpec® instrument for the detection of COVID-19 using non-invasive breath testing and analysis having met the requirements of the European In-Vitro Diagnostics Directive (98/79/EC).
BreathSpec®'s intended use is for the diagnosis of respiratory tract infections with specific utility for SARS-CoV-2 (Covid-19) in a Point of Care setting by clinicians and non-technical users. In collaboration with University Hospitals of Leicester NHS Trust, University of Warwick, National Hospital of Kandy, Sri Lanka and British Columbia Cancer Foundation, Canada, breath samples were collected, analyzed and shown to correlate to Polymerase Chain Reaction testing, the current standard of testing for Covid-19.
Breathspec® is Imspex's proprietary breath analyzer using a unique combination of gas chromatography (GC) and ion mobility spectrometry (IMS) technologies to deliver fast and accurate results. The key advantage of non-invasive sample collection from patients is particularly beneficial to children and challenged patients with significant time and cost savings versus PCR testing.
"This is a global first for breath-based Covid-19 testing and a major step towards our mission to bring breath-based testing into the mainstream" said John McKinley, CEO of Imspex Diagnostics. "BreathSpec® confirms that the new age of non-invasive testing for Covid-19 and other diseases is now within reach, offering alternative testing pathways for healthcare providers and economies of cost and supply chain to healthcare administrators working across diverse diseases."
Imspex received technical support from the University of South Wales, grant and funding from The Welsh Government, Development Bank of Wales, Angel CoFund, Innovate UK and angel investors.
About Imspex Group
Imspex is a leader in Breathomics, the non-invasive way to address major healthcare challenges. Years of technology development have delivered a range of instruments across multi-industry sectors evidencing Imspex's leadership status. Breath collection and analysis is carried out using Imspex's lead instrument, BreathSpec®. Our mission is to harness the potential of breath-based testing and diagnosis and to provide cutting-edge analytics solutions where early warning signals are needed. Our versatile combination of gas chromatography (GC) and ion mobility spectrometry (IMS) has a proven track record in medical detection and diagnosis scenarios and in diverse industrial locations, including biogas contamination detection, food and beverage processing and wastewater pathogen detection.
Please visit www.Imspex.com
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